Biosimulation (a term that includes model informed drug discovery and development) uses computer-based mathematical simulations derived from preclinical and clinical data to replicate biological processes, dynamics, and systems (1). By integrating and quantifying information about the drug, disease, how the drug affects the human body (pharmacokinetics [PK]), and how the body responds to the drug (pharmacodynamics), biosimulation optimizes decision-making. Used in most novel drug development programs today, it can predict clinical outcomes, inform clinical trial design, support evidence of effectiveness, and improve safety profiles by predicting drug–drug interactions (DDIs), and optimizing dosing. Biosimulation, which accelerates drug development, is actively used across the industry, and encouraged by FDA and other global regulators.

In the context of formulation development, a key biosimulation approach, termed model informed formulation development (MIFD), is used to determine the 

 correlation and/or extrapolation (IVIVC/IVIVE), a predictive mathematical model describing the relationship between an 

 PK or response. IVIVC is used to establish a predictive relationship between 

 drug absorption. IVIVC can be numerically based, for drugs with a simpler, often linear relationship between absorption and dissolution, or mechanistically based (also called physiologically based pharmacokinetics modeling, or PBPK), for more complex products.

Based on decades of data and advancements in mathematical modeling, currently available PBPK models can help simulate the transit, disintegration, dissolution, precipitation, and absorption of drug from a particular formulation and include population variability. Moreover, PBPK models can help evaluate the fate of a formulation in different prandial states such as fasted vs fed conditions, in a pediatric vs adult gastrointestinal (GI) tract, in subjects with achlorhydria, etc. PBPK models can also help assess and optimize the role of excipients on drug solubility, dissolution, and absorption, evaluate the salt selection and solid-state polymorphism, enabling formulations to be examined under 

 conditions without performing clinical studies.

Pharmaceutical Technology’s October 2023 Trends in Formulation eBook

is senior director of PBPK Consultancy Services, 

 is senior vice president and chief commercial officer, both at the Simcyp division of Certara

When referring to this article, please cite it as Patel, N.; Leinfuss, E. Advancing Oral Drug Development Using MIFD. 

Pharmaceutical Technology’s Trends in Formulation eBook 

Articles

Development

Model informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.

Advancing Oral Drug Development Using MIFD

The production of safe and effective medicines requires access to reliable manufacturers of APIs. However, increasing pressure to reduce market prices of drugs has created deeper challenges for API sourcing organizations, often leading them to consider lower quality and less reliable suppliers. This is a short-sighted approach. Particularly as global quality standards become more harmonized, there are now higher expectations across the globe. And with COVID-19, reliability has also become a top-of-mind topic for manufacturers and healthcare systems.

The best approach to overcoming these challenges is finding a balance in the total cost of manufacturing and selling medicines, also referred to as total cost of ownership, with the right quality API at the right (not cheapest) price.

When referring to this article, please cite it as Badrot, A. Optimizing the Total Cost of Ownership for APIs. 

Quality

All members of the pharmaceutical supply chain must implement reliable sourcing and manufacturing strategies that balance quality and costs to ensure the uninterrupted supply of high-quality medicines to patients worldwide.

Optimizing the Total Cost of Ownership for APIs

Development of any new drug product from concept to commercialization requires detailed understanding of drug properties, excipients, manufacturing processes, analytical methods, and regulatory requirements in target markets. Solid oral dosage forms are the preferred delivery route, and it is vital to select the right core excipients early in the development process to ensure stability, performance quality attributes, patient acceptance, and manufacturability. 

Self-service digital platforms are designed to address the complexity of developing a new drug product, through automating formulation and process recommendations.

Shahrzad Missaghi, PhD, is senior manager—Product Development, and Jason Hansell is global technical excellence manager; both at Colorcon.

When referring to this article, please cite it as Missaghi, S.; Hansell, J. The New Digital Era for Formulation Development. 

A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.

The New Digital Era for Formulation Development

As CPHI Barcelona approaches, the pharmaceutical world is gearing up to explore promising innovations that could shape the future of healthcare. This year is historic for CPHI, as it introduces a dedicated exhibition zone exclusively for start-ups, which are the innovation hubs of the industry. As part of its overarching mission to accelerate the journey of innovative medicines to patients worldwide, CPHI is shining a spotlight on some of the most promising early-stage technological innovations poised to impact the global pharmaceutical landscape. In this context, we had the privilege to engage with two emerging start-ups, one in the realm of devices and the other specializing in enhancing solubility, both offering unique solutions set to reshape the pharmaceutical landscape.

This article was written by the CPHI Content Team.

When referring to this article, please cite it as CPHI Content Team. Innovative Start-Ups at CPHI Barcelona. 

Pharmaceutical Technology Trends in Formulation

The Start-Up Market at CPHI Barcelona will bring together 27 start-ups, innovators, and small enterprises from across the pharma landscape.

Innovative Start-Ups at CPHI Barcelona

When considering manufacturing and the growth of drug formulation, it is evident that there has been change and many new advancements introduced to make processes more efficient. However, in terms of formulating highly potent drugs, their specific release requirements and poor aqueous bioavailability make them challenging to produce and analyze (1).

Although there may be difficulties seen with analytical challenges, the strength of oral solid dosage (OSD) forms and the manufacture of all pharmaceutical finished dosage forms continues to be prominent. According to research, the OSD market outlook is expected to continue growing and have low production costs, even with the knowledge of how unpredictable formulation may become (2).

 discussed new formulation trends with Shailesh Vengurlekar, senior VP of Quailty and Regulatory Affairs at LGM Pharma, and how the industry can go forward with these advancements, despite any challenges that may arise.

Read this article in the Trends in Formulation 2023 eBook

When referring to this article, please cite it as J. Murphy, "Trends in Formulation for Highly Potent Drugs," 

's Trends in Formulation eBook (October 2023).

Formulation

When considering manufacturing and the growth of drug formulation, it is evident that there has been change and many new advancements introduced to make processes more efficient. 

Trends in Formulation for Highly Potent Drugs

This year’s CPHI heads to Barcelona from October 24–26, 2023 at the Fira de Barcelona. The worldwide event will bring together innovative businesses and thought leaders under one roof.“We are excited to welcome the industry back to the heart of pharma. CPHI Barcelona presents a one-of-a-kind experience this year, merging the best of online and on-site experiences with exhibition, seminars, workshops, and our Event Planner app. There will also be fresh opportunities to forge valuable connections and discover the latest innovations in our vibrant start-up market,” says Sherma Ellis Daal, brand director, Pharma at Informa Markets. The following is an exclusive interview with Daal for 

This interview was conducted and prepared by the CPHI Content Team.

When referring to this article, please cite it as CPHI Content Team. Welcome to CPHI Barcelona. 

Sherma Ellis Daal, brand director, Pharma at Informa Markets, gives a preview of CPHI Barcelona 2023. 

Welcome to CPHI Barcelona

Ahead of CPHI Barcelona, which will occur October 24–26, 2023, the CPHI Annual Report explores future trends, challenges, and opportunities (1). Featuring a panel of more than 12 industry analysts and insights from 400 pharmaceutical executives, the report provides a window into both near-term and medium-term opportunities in the pharma sector. In this article, the author delves into the implications of artificial intelligence (AI) on drug development and pharmaceutical manufacturing.

Bikash Chatterjee is president and chief science officer at Pharmatech Associates–a USP Company.

When referring to this article, please cite it as Chatterjee, B. The Impact of AI on Pharma. 

CPHI’s Annual Report predicts huge impact of AI on drug development and manufacturing.